PB1941: MIND-BODY INTERVENTION PROLONGS LYMPHOCYTE DOUBLING TIME AND TREATMENT-FREE SURVIVAL IN TREATMENT-NAÏVE CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS
Authors: Shirley Shapira, Adi Zoref Lorenz, Naama Hirschberger, Barak Mizrahi, Ohad Benjamini, Esti Mandel, Yishai Ofran
Journal: HemaSphere (2023)

Topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical Background: Mind-Body intervention (MBI) is effective in several benign medical conditions. Association between cancer and stress has been proven, and is attributed to several mechanisms including activation of Hypothalamus-Pituitary-Adrenal axis. In oncology, MBI is used as supportive aid to improve patients’ quality of life and adherence to treatment. Aims: We hypothesized that MBI could impact the course of Chronic Lymphocytic Leukemia (CLL) in the watch and wait phase (W&W). Methods: Cognitive Cell Re-Coding (CCRC), an MBI model, was utilized in a non-randomized prospective controlled study between February 2020 and February 2022 in 79 treatment-naïve patients with CLL in the W&W. Thirty-seven patients were in the intervention group and 39 in the control. The two groups were well balanced in all biological parameters. CCRC model was designed by the Principal Investigator and comprises of three levels: i) ‘Behavioral’ level which aims to promote relaxation and parasympathetic activity by using several measures such as meditation and mindfulness, ii) ‘Psychological’ level aiming to unmask root/basic beliefs from the subconscious in order to promote awareness, and iii) ‘Spiritual’ level aiming to connect with transcendent existence. The intervention included both individual and group meetings, and lasted from enrollment until the end of the trial – a median of 18 months. The primary end-point was a prolongation of lymphocyte doubling time (LDT), and the secondary end-point was defined as treatment-free survival (TFS) in the intervention group compared to the control group. LDT was monitored prospectively; pharmacological treatment starting dates were recorded. The prolongation of LDT was compared between day 0 and days 180, 360, and 540 using a paired t-test. TFS was compared between the intervention and the control group using the log-rank test. Finally, the predictive value of different demographic, clinical and laboratory parameters was calculated using cox regression Results: We found that MBI prolonged LDT at day 180 (mean difference (MD) 1.42 years; 95% confidence interval (CI) 0.23-2.26; p= 0.02), day 360 (MD 2.47 years; CI 1.05-3.9; p= 0.001) and day 540 (MD 3.24 years; CI 1.76-4.76; p= 0.0001). TFS at 18 months was longer in the intervention group compared to the control group (Hazard ratio (HR) 0.23; CI 0.06-0.79, p=0.01). Milder disease (HR 0.09; CI 0.01-0.73, p=0.02), initiation of the CCRC intervention within five years from CLL diagnosis (HR 0.09; CI 0.01-0.71, P=0.02), and male gender (HR 0.11; CI 0.01-0.89, p=0.04) were predictive of better TFS with MBI. Cytogenetics abnormalities and Immunoglobulin Heavy chain Variable (IgHV) mutation status did not impact the efficacy of MBI Summary/Conclusion: In this study, CCRC intervention prolonged LDT and TFS in the W&W of CLL. These results provide a basis for a larger randomized-control trialKeywords: Chronic lymphocytic leukemia